Electronic Data Capture At Emory University

1. Electronic Data Capture At Emory University Research and Health Sciences IT Division

2. Research Scenarios An investigator wants to collect discrete data at single or multiple sites for a prospective or retrospective study An investigator sees patients, and would like to capture data in the clinical flow which can then be extracted and analyzed as discrete elements for research For a broad population, an investigator would like to email a link to participants for them to fill out an unadministered survey

3. Other Requirements Integrate data from existing sources into the database Utilize standardized instruments (e.g., SF-36) International sites FDA regulated (Part 11 compliance) or VA-owned data

4. Current Environment for EDC • Departments • DataFax (Biostatistics) • Oncore (Cancer) • LAVA (Neurology) • Centrally Supported • PowerForms • PowerNotes • REDCap • Feedback Server • Clinical Research Office (CRO) • Supplied system/forms • Investigator • Microsoft Excel • Microsoft Access • Survey Monkey • Custom Web App

5. REDCap • Flexible design interface • Standard or longitudinal modules • Double data entry module • Multiple field types • File upload for individual records • Ability to set up parent/child relationships between studies • Skip logic for validation • HIPAA compliant data storage

6. Study Management Tools in REDCap Detailed user access control based on Emory University active directory Calendar tool and online document repository Auditing tools Tool to lock records Electronic signature

7. Analytical Tools In REDCap Graphic tools to view simple statistics Export data easily in formats for many statistical packages including SAS, SPSS, STATA, and R. Import data from external sources like the clinical data warehouse or lab result spreadsheets

8. Feedback Server • Complex conditional rules and skip logic • Detailed layout and design options • Create and utilize question libraries • Print as a Word document • Allow respondents to save progress and return at any time • Unlimited pages and questions

9. Management Tools inFeedback Server Secure user access control for survey designers using Emory’s Active Directory Various security layers to protect and close survey access Create and track email distribution lists Import existing data View web-based reports, or export data to csv/Excel, SPSS/SAV and XML

10. Form and Research Design Appropriate validation and integrity controls, limiting the number of text fields Consistency with Y/N/Unk questions Above all else…”Is your form gathering the data necessary for you to answer your research question?”

11. Skill Sets • One key consideration is the available skill set to create and modify forms • Generally, the more complex the functionality, the greater the technical skill set to perform • REDCap: creating an initial form entails adding data to an Excel spreadsheet. However, adding complex skip logic requires a little script writing • Each platform has its own baseline skill requirement • LAVA: creating a new form entails Java programming

12. Extension of Platforms Greater integration with data repositories and registries Creation of a library of reusable forms Common form authoring tool to ensure the use of standard terminologies Integration with study management, recruitment, study calendars, etc.

13. REDCap and Feedback Server • Offered as a service through the Research IT Service Center • REDCap: • $600/year per study (a study can have multiple forms) • Feedback Server: • $220/year (SurveyMonkey model) • Though pretty intuitive, ability to act as a consultant to create forms @ $65/hour

14. Research & Health Sciences IT Division Contacts • REDCap – Kathryn Claypool • kathryn.claypool@emory.edu • Feedback Server – Bill Szabrak • bill.szabrak@emory.edu • Data extraction – Jeff Weaver • jeff.weaver@emory.edu